Using peptide-HLA tetramer technology, antigen-specific T cells can be identified and isolated in individuals carrying specific HLA types. Using influenza haemagglutinin (HA)306-318-HLA-DRB1*04:01 tetramers, we previously demonstrated antigen-specific CD4+ T cells amongst peripheral blood mononuclear cells (PBMC) of healthy HLA-DRB1*0401+ human donors, of which 50-90% had a phenotype of CD25+Foxp3+CD45RO+ or CD45RO- regulatory T (Treg) cells. The aim of this study was to clone and characterize the function of HA-specific CD4+ T cells using single-cell-sorting from PBMC prepared from a healthy HLA-DRB1*0401+ human donor. Single pHLA-tetramer+ cells were sorted into wells with allogeneic feeder cells, stimulated with mitogen and expanded with IL-2. Of the 32 clones which were generated, 19 responded specifically to HA peptide restimulation. Although slow-growing in the presence of 50 IU/ml IL-2, these clones were easily expanded in presence of 300 IU/ml of IL-2 and anti-CD3/CD28-coated beads. By flow cytometry, 3/4 expanded pHLA-tetramer+ clones were CD4+ CD25+ FOXP3high CD45RA-, characteristic of activated Treg cells. We examined their suppressive function by co-culture of equal numbers of autologous conventional T cells and cloned cells for six days, in presence of anti-CD3/CD28-coated beads. In response to this polyclonal stimulus, both pHLA-tetramer+ and pHLA-tetramer- Foxp3+ clones suppressed conventional T cell proliferation. These preliminary data indicate that CD4+ clones with regulatory function can be expanded from healthy donors based on single-cell sorting of pHLA tetramer+ T cells directly ex vivo.